A leaked draft TPP annex with the Orwellian title “Transparency and Procedural Fairness for Healthcare Technologies” would set broad limits on governments’ prerogatives to negotiate or mandate lower drug prices, including for taxpayer-funded programs such as Medicare, Medicaid and veterans’ and military health programs. Pushed by U.S. negotiators, these proposed TPP rules would conflict with existing and proposed policies to reduce healthcare costs for seniors, military families and the poor.

However, this cost-saving mechanism could run afoul of the proposed TPP annex, which requires government drug reimbursements to be based on “competitive, market-derived prices,” or on a system that “appropriately recognizes[] the value” of the drugs. The government-mandated price-setting system for VA programs would be subject to challenge as not being “competitive” and “market-derived.” VA-secured prices that fall significantly below the prices of patented drugs also could be challenged under the TPP as not “appropriately recognizing” drugs’ value. These TPP provisions, if enacted, could expose the U.S. government to challenges before international tribunals for not rolling back policies that cut healthcare costs for veterans and taxpayers.

Threatening policies that make medicines more affordable for the poor:

State governments can further cut costs by, for example, negotiating lower prices with drug companies in return for placing their medicines on a Preferred Drug List (PDL) – a list of medicines that the state’s Medicaid program will cover without requiring prior authorization from a doctor. States have calculated substantial cost savings from usage of PDLs: New York saved an estimated $381 million in one recent year, while Texas saved an estimated $115 million and Utah saved an estimated $434 million.

Such Medicaid cost containment measures could be challenged under the TPP. Leveraging the government’s buying power to set prices could be attacked as not being “market-derived” or as “appropriately recognizing” the value of patented drugs. Some argue that the TPP provisions would primarily target federal policies, while Medicaid is administered by state governments. But even if limited to federal policies, the pact’s proposed terms directly contradict Medicaid’s federal cost control efforts, such as requiring drug firms to sign discount agreements. And state-level tools like PDLs could still be challenged under the TPP as part of a program created and controlled by the federal government.

Challenging Obamacare cost reductions for seniors:

Before implementation of the landmark Patient Protection and Affordable Care Act of 2010, seniors faced a gap in Medicare drug coverage. After passing a given threshold of drug costs, Medicare beneficiaries went from having to pay 25 percent of a drug’s cost to having to pay 100 percent out of pocket, until reaching a second threshold at which Medicare again covered most costs. Closing this “doughnut hole” was a key objective of the Affordable Care Act, which required drug manufacturers to offer a 50 percent drug price discount to Medicare beneficiaries within the coverage gap if they wanted their drugs to continue being covered under Medicare. As a result of this discount and a gradual increase in Medicare coverage, Medicare beneficiaries within the coverage gap were only responsible for 47.5 percent of brand-name drug costs in 2013 and will be responsible for only 25 percent by 2020.

But under the TPP, the requirement for drug companies to halve the price of their drugs within the coverage gap could be challenged for neither reflecting “competitive market-derived” prices nor “appropriately recognizing[] the value” of patented drugs. The Obama administration’s TPP healthcare annex thus threatens the cost savings that the administration’s own signature health law has provided to seniors.

Chilling future reforms that could further reduce healthcare costs for retirees:

Governments in countries ranging from New Zealand to Japan have kept healthcare costs in check by leveraging the government’s large purchasing power for taxpayer-funded public health programs to negotiate lower drug prices with pharmaceutical corporations. In contrast, for Medicare, which covers more than 50 million Americans, the U.S. government is barred by law from directly negotiating drug prices with pharmaceutical corporations.

Many policymakers, healthcare professionals and even President Obama have called for changes to this law so that the government could ask drug companies to provide lower prices in exchange for getting subsidized access to millions of Medicare recipients. Other reform proposals, including legislation now pending, would have the federal government set maximum prices for drugs covered by Medicare (as it does for health programs provided to veterans) or require that drug companies provide drug rebates (similar to the rebates required under Medicaid). Indeed, the White House itself has proposed requiring drug companies to pay Medicaid-like rebates to providers for treating low-income Medicare beneficiaries. The administration estimates this would deliver $117 billion in savings over 10 years.

However, the TPP presents an obstacle to these proposals to control soaring Medicare costs. All of the above-mentioned policies involve direct government intervention in price setting, conflicting with the TPP requirement for market-derived prices, and inviting challenges for failing to “appropriately recognize” the value of patented drugs.

As a federally-run program that mandates below-market prices, the program could be challenged as a violation of the proposed TPP rules requiring drug prices to be market-derived or to reflect the value of patented drugs. In addition, the leaked TPP annex would require the U.S. government to allow pharmaceutical corporations to appeal drug pricing decisions such as the rebate amounts set under the 340B program, though they have very limited appeal rights for such decisions under U.S. domestic law. The TPP would thus give pharmaceutical corporations a new means of challenging 340B policies that reduce drug prices for underserved populations.

Leaked draft intellectual property texts for the TPP reveal broad monopoly protections for pharmaceutical corporations, which elevate the costs of medicines and medical procedures. Inserting these sweeping corporate privileges into the pact would undermine U.S. efforts to make healthcare more affordable.

Some of the leaked TPP monopoly protections for Big Pharma could require scrapping the Obama administration proposal to save more than $4 billion on biologic medicines. Biologics – the latest generation of drugs to combat cancer, rheumatoid arthritis and other diseases – are exceptionally expensive, costing approximately 22 times more than conventional medicines.

Under U.S. law, pharmaceutical corporations enjoy monopoly protections for biologic drugs, even in the absence of a patent, for a 12-year period of “exclusivity.” During these 12 years, the Food and Drug Administration is prohibited from approving more affordable versions of the drugs, inflating the cost of these life-saving medicines as pharmaceutical firms accrue monopoly profits.

To lower the exorbitant prices and the resulting burden on programs like Medicare and Medicaid, the Obama administration’s 2015 budget would reduce the exclusivity period for biologics from 12 to seven years. The administration estimates this would save taxpayers more than $4.2 billion over the next decade just for federal programs.

However, at the request of Big Pharma, U.S. trade negotiators are demanding the 12-year exclusivity requirement for biologics in the TPP. This would lock into place pharmaceutical firms’ lengthy monopolies here at home. That is, Obama administration negotiators would effectively scrap the administration’s own proposal to save billions in unnecessary healthcare costs and lock in rules that would forbid future presidents or Congresses from doing so.

Another TPP text - the leaked draft investment chapter - reveals that the deal would grant foreign firms the power to skirt domestic courts, drag the U.S. government before extrajudicial tribunals, and directly challenge patent laws and medicine cost containment policies as violations of their new TPP foreign investor “rights.”

The tribunals, comprised of three private attorneys, would be authorized to order unlimited taxpayer compensation for domestic policies perceived as undermining pharmaceutical corporations’ “expected future profits.” Effectively, this system would elevate individual pharmaceutical firms to the same status as the countries that may sign the TPP, empowering such firms to privately enforce the public agreement.

Such extreme “investor-state” rules have been included in past U.S. “free trade” agreements, forcing taxpayers to pay firms more than $430 million for toxics bans, land-use rules, water and timber policies and more. Just under U.S. pacts, more than $38 billion is pending in corporate claims against patent policies, pollution cleanup requirements, climate and energy laws, and other public interest polices.

This includes a $500 million claim that U.S. pharmaceutical corporation Eli Lilly launched in 2013 against Canada’s legal standard for granting patents. The firm is demanding compensation because Canadian courts enforcing Canadian patent law ruled that two of Eli Lilly’s medicines failed to meet the Canadian standard to obtain a patent, which requires demonstrating a drug’s promised utility. This is the first attempt by a patent-holding pharmaceutical firm to use the extraordinary investor privileges provided by U.S. “trade” agreements as a tool to push for greater monopoly patent protections.

The TPP would vastly expand the investor-state threat to U.S. public health policies, given the thousands of corporations based in TPP countries that would be newly empowered to launch cases against U.S. laws on behalf of any of their more than 14,000 U.S. subsidiaries.

Stay tuned for post #3 on yet another way that the TPP could limit the U.S. government's ability to control rising drug costs.

Americans pay far more for healthcare than people in any other developed country, even though U.S. life expectancy falls below the average for developed countries. A major contributor to our bloated healthcare costs is the high prices for medicines in the United States. According to the Government Accountability Office, U.S. drug prices increased more than 70 percent faster than prices for other healthcare goods and services over 2006-2010. As a result, millions of Americans cannot afford the medicines they need to live healthy lives.

To try to combat the twin problems of unaffordable healthcare and unsustainable deficits, U.S. federal and state governments already use several tools to tamp down the cost of drugs – for Medicare, Medicaid and for military healthcare under TRICARE and the Department of Veterans Affairs (VA). Many more such cost containment policies have been proposed.

Yet, the TPP threatens to chill such proposals and even roll back existing policies to rein in exorbitant medicine prices. Leaked draft TPP texts – an intellectual property chapter, investment chapter and healthcare annex – contain expansive rules that would constrain the ability of the U.S. government to reduce medicine prices. Getting these terms into the TPP was a key objective of large U.S. pharmaceutical corporations that stand to reap monopoly profits from expansive patent terms and restrictions on government cost containment efforts. This incentive may explain why pharmaceutical corporations have lobbied Congress for the TPP more than any other industry.

The TPP’s threats to the affordability of U.S. healthcare have spurred major groups that have not traditionally taken part in trade policy debates to warn against the TPP’s provisions. For example, AARP – representing more than 37 million Americans over the age of 50 – joined unions and consumer groups in a November 2013 letter to President Obama to express “deep concern” that texts proposed for the TPP would “limit[] the ability of states and the federal government to moderate escalating prescription drug, biologic drug and medical device costs in public programs.” The groups concluded that the TPP could “undermine[] access to affordable health care for millions in the United States and around the world.”

Because it would mask the erosion of U.S. manufacturing incentivized by offshoring-friendly policies, including a raft of unfair trade deals. The Orwellian proposal would undermine efforts to replace more-of-the-same policies with a fair trade model.

Under the proposal, reported U.S. “manufacturing” jobs and wages would balloon overnight, as brand managers and programmers would suddenly be counted as “manufacturing” workers. The broad reclassification initiative would also deceptively deflate the large U.S. manufacturing trade deficit. U.S. imports of made-in-China iPhones would not be tallied as manufactured goods imports but as imports of Foxconn's “services,” while iPhones exported from China to, say, Europe would actually be rebranded as “U.S.” manufacturing exports.

During an official period to comment on the proposal, Public Citizen, many labor groups, and other allies invited people to send their two cents to the administration. The response was overwhelming.

This past Friday, the administration responded. This announcement appeared in the Federal Register:

“Given these initial research results and the large number of public comments submitted on the topic of FGPs [Factoryless Goods Producers], OMB [the Office of Management and Budget] here announces that the FGP recommendation will not be implemented in 2017.”

If you submitted a comment, congratulations. According to the administration, your voice of reason contributed to a chorus that helped convince the administration to rethink the wisdom of categorizing firms that do not manufacture anything as U.S. manufacturers. Advocacy, as it turns out, can work.

Please place your hand above your back and pat vigorously. But don’t break out the champagne glasses.

Thanks to the groundswell of public opposition (and the contributions of some clear-minded naysayers within the administration), the “factoryless goods” proposal has been shelved. But it has not been dustbinned.

OMB makes clear that the “factoryless goods” fantasy will likely emerge again, albeit in a different form:

“Without the deadline imposed by the 2017 NAICS revisions, the relevant statistical agencies will now have the opportunity to complete the additional research, testing, and evaluation needed to determine the feasibility of developing methods for the consistent identification and classification of FGPs that are accurate and reliable. This process will also be informed by questions raised in public comments. Results of this research, testing, and evaluation could lead to a different FGP proposal for consideration or implementation.”

As "factoryless goods" proponents regroup and decide what to do next, we will remain vigilant. Future bouts of pressure will likely be needed to keep our data, and the policymaking that it informs, free of distortion. As we push to change our trade policies, we will need to keep pushing against efforts to simply change our numbers.

CAFTA proponents promised the deal would reduce gang and drug-related violence in Central America, boost economic development, and diminish the factors pushing Central Americans to migrate to the United States.

Such promises already sounded hollow when they were voiced in 2005. Today, as thousands of Central American children leave their homes and risk their lives to try to make it to the United States, CAFTA’s promises have proven tragically empty.

When trying to secure passage for CAFTA’s expansion of the controversial North American Free Trade Agreement (NAFTA) model to five Central American nations and the Dominican Republic, the Bush administration and corporate lobbyists could not rely on the standard promises of job creation and deficit reduction that had proven false under NAFTA. Instead, they launched a barrage of political arm-twisting and horse-trading to convince members of Congress to vote against the anti-CAFTA opinions of their constituents.

Many CAFTA backers also resorted to selling the deal as a pathway to peace and prosperity for Central America. Here is Representative Tom Davis (R-Va.) speaking on the House floor in favor of CAFTA on July 27, 2005:

“…we need to understand that CAFTA is more than just a trade pact. It's a signal of U.S. commitment to democracy and prosperity for our neighbors. And it's the best immigration, anti-gang, and anti-drug policy at our disposal…Want to fight the ever-more-violent MS-13 gang activity originating in El Salvador but prospering in Northern Virginia? Pass CAFTA …Want to begin to ebb the growing flow of illegal immigrants from Central America? Pass CAFTA.”

One day later, Congress passed CAFTA.

Nine years later, gang and drug-related violence in Central America has reached record highs and the “growing flow” of immigrants from Central America has surged.

On Wednesday, Miriam Miranda, coordinator of the Fraternal Black Organization of Honduras (OFRANEH) traveled to Washington, D.C. to speak to congressional staff about the rampant violence and unrelenting poverty in her home country and its neighbors. Miriam spoke not only of the skyrocketing homicides and widespread gang and paramilitary control in Honduras, but the economic instability undergirding such violence.

I asked Miriam what she would say, if given the opportunity, to the members of Congress who had promised CAFTA would spur development and reduce violence and migration pressures in Central America. She responded:

“It’s more than evident with what has happened in the last eight to nine months – this massive exit from Central America – that these policies that they have implemented are completely mistaken. They don’t respond to our needs…We have to question this model of development – development for whom?”

Not only did CAFTA fail to stem violence and migration from Central America as Rep. Davis and other proponents promised. The deal appears to have actually contributed to the economic instability feeding the region’s increase in violence and forced migration.

That’s the conclusion reached by the 67 members of Congress’ Progressive Caucus, who included CAFTA in their recent summary of the root causes of the refugee crisis occurring along the U.S.-Mexico border: “free trade agreements, including the North American Free Trade Agreement (NAFTA) and the Central America Free Trade Agreement (CAFTA) have led to the displacement of workers and subsequent migration from these countries.”

How has CAFTA led to displacement and migration? Under CAFTA, family farmers in Honduras, El Salvador, and Guatemala have been inundated with subsidized agricultural imports – mainly grains – from U.S. agribusinesses. Agricultural imports from the United States in those three CAFTA countries have risen 78 percent since the deal went into effect.

While agricultural exports to Central America represent a small slice of U.S. agricultural corporations’ business, they present a large threat to the livelihoods of small-scale Central American farmers who cannot compete with highly subsidized and mechanized U.S. firms. When Mexico experienced a similar surge in agricultural imports under NAFTA, more than 2 million Mexican farmers and agricultural workers lost their livelihoods and migration to the United States doubled.

In the lead-up to CAFTA, development groups like Oxfam warned of such displacement, stating that when considering the impacts on Central American rice production alone, CAFTA threatened the livelihoods of up to 1.5 million people in the region. Central American immigrant advocacy groups like CARECEN, CONGUATE, and SANN also raised such concerns early in the CAFTA negotiating process, but were ignored by the Bush administration.

Certainly the economic instability and violence plaguing Central America, and the resulting surge in migration to the United States, cannot be pegged on CAFTA alone. The causes of the crisis are manifold, and many have beenamplydiscussed. But though CAFTA did not singlehandedly spark this fire, it appears to have contributed to the kindling.

And clearly, CAFTA has utterly failed to deliver on the far-fetched promises used by Rep. Davis and other proponents to sell the controversial deal to a skeptical Congress back in 2005. I wish Representative Davis, and all those who voted for CAFTA, would have been there on Wednesday to hear Miriam’s words.

I wish the same for the members of the Obama administration who are now pushing to expand the NAFTA/CAFTA trade model across the Pacific under the Trans-Pacific Partnership (TPP). As with CAFTA, some are trying to sell that deal with rosy promises that it will spur development in TPP countries.

About Us

Eyes on Trade is a blog by the staff of Public Citizen's Global Trade Watch (GTW) division. GTW aims to promote democracy by challenging corporate globalization, arguing that the current globalization model is neither a random inevitability nor "free trade." Eyes on Trade is a space for interested parties to share information about globalization and trade issues, and in particular for us to share our watchdogging insights with you! GTW director Lori Wallach's initial post explains it all.

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